Effect of LY3314814 on the Pharmacokinetics of Dabigatran in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK) : Maximum Concentration (Cmax) of Dabigatran
研究概览
简要总结
The purpose of this study is to learn about the effect of lanabecestat on how the body absorbs and processes dabigatran etexilate and how dabigatran etexilate affects lanabecestat when they are taken together. This study will last about 28 days and participants will be asked to take an lanabecestat tablet daily for 19 days and a dabigatran etexilate tablet on 3 occasions. Screening is required within 30 days prior to the start of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overtly healthy males and females
排除标准
- •Eye abnormalities or disease
- •History of vitiligo or any skin color disorder
- •Have a history psychiatric or brain disease including seizures
- •Have smoked within the last 3 months
- •Are unwilling to avoid food and drinks containing grapefruit or Seville oranges for the duration of the study
- •Have known allergies to dabigatran etexilate and related compounds
研究组 & 干预措施
Dabigatran Etexilate
Single dose of dabigatran etexilate administered orally.
干预措施: Dabigatran etexilate (Drug)
Lanabecestat and Dabigatran Etexilate
Single dose of lanabecestat administered orally once daily on Days 3 to 21. Single doses of dabigatran etexilate administered orally on Days 16 and 20 during the lanabecestat dosing.
干预措施: Lanabecestat (Drug)
Lanabecestat and Dabigatran Etexilate
Single dose of lanabecestat administered orally once daily on Days 3 to 21. Single doses of dabigatran etexilate administered orally on Days 16 and 20 during the lanabecestat dosing.
干预措施: Dabigatran etexilate (Drug)
结局指标
主要结局
Pharmacokinetics (PK) : Maximum Concentration (Cmax) of Dabigatran
时间窗: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose
Pharmacokinetics: Area Under The Dabigatran Pharmacokinetic (PK) Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity)
时间窗: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose
次要结局
- Pharmacokinetics: Area Under the Lanabecestat Pharmacokinetic (PK) Concentration Versus Time Curve During One Dosing Interval (24 Hours) (AUCtau)(Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
- Pharmacokinetics: Maximum Concentration (Cmax) of Lanabecestat(Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose)
- Pharmacodynamics: Area Under the Effect Versus Time Curve (AUEC) of Thrombin Time(Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose)
- Pharmacodynamics: Ratio of Maximum Effect to Baseline Effect (ERmax) of Thrombin Time(Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose)